ANI Pharmaceuticals Inc. (ANIP) has sought FDA approval for its purified Cortrophin Gel for multiple indications including multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome – and a decision is expected on October 29, 2021.The company acquired the NDA for Cortrophin Gel from Merck in January of 2016 and spent over four years and over $100 million to re-establish and validate the commercial corticotropin active pharmaceutical ingredient (API) and Cortrophin Gel drug product manufacturing processes.Cortrophin Gel was originally approved by the FDA in 1954 but was withdrawn from the market in the 1980s.If approved, Purified Cortrophin Gel will have to compete with Mallinckrodt's H.P. Acthar Gel, the sole product in the repository corticotropin market which is estimated to have annual sales of approximately $640 to $700 million in the next three years.ANIP closed Wednesday’s trading at $33.98, up 3.60%.